Evaluation of Intensive Language Therapy

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-10-24

Brief Summary

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Due to Parkinson's Disease (PD) speech and language (SL) deficits may occur. Further, the literature reports that PD patients, who have not undergone deep brain stimulation (DBS), have deficits regarding voice quality (e.g. loudness and intelligibility of their voice), while PD patients who have undergone DBS suffer from deficits in word retrieval and speech apraxia symptoms. To-date, therapeutic approaches focusing specifically on SL deficits observed in PD-DBS patients are yet to be developed and evaluated.

Therefore, this study investigates the short-and longterm effectiveness of specific and intensive, high-frequency speech-language therapy in terms of reducing SL-deficits compared to a nonspecific and non-verbal sham treatment (i.e. a rhythmic balance-movement training (rBMT)) as well as to a 'no-therapy' condition.

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Detailed Description

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In the course of Parkinson's disease (PD) speech and language (SL) deficits may often emerge. In addition, severe verbal fluency (VF) decline has been repeatedly observed in the context of deep brain stimulation (DBS) in PD. Interestingly, while PD non-DBS patients have deficits with respect to loudness and intelligibility of their voice, PD patients who have undergone DBS (PD-DBS) suffer rather from difficulties in semantic and phonemic word retrieval, and from speech apraxia symptoms.

However, to-date and to the best of our knowledge, therapeutic approaches focusing specifically on SL deficits observed in PD-DBS patients are yet to be developed and evaluated regarding their effectiveness. Thus, this study investigates the short-and longterm effectiveness of specific and intensive, high-frequency speech-language therapy in terms of reducing SL-deficits compared to a nonspecific and non-verbal sham treatment (i.e. a rhythmic balance-movement training (rBMT)) as well as to a 'no-therapy' condition.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Specific SL-therapy for PD (with and without DBS)

Rhythmic specific, intensive and high-frequency SL-therapy. Approx. 45 Min. per session, 3 times per week for 4 weeks

Group Type EXPERIMENTAL

Specific SL-therapy

Intervention Type OTHER

Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.

Rhythmic Balance-Movement Training (rBMT)

Intervention Type OTHER

Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.

rBMT for PD (with and without DBS)

Rhythmic Balance-Movement Training (rBMT); approx. 30-45 Minutes per session, 3 times per week for 4 weeks

Group Type ACTIVE_COMPARATOR

Specific SL-therapy

Intervention Type OTHER

Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.

Rhythmic Balance-Movement Training (rBMT)

Intervention Type OTHER

Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.

PD (with and without DBS); no therapy

No further recruiting necessary, as data is already at hand via previous research projects.

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy Controls; no therapy

No further recruiting necessary, as data is already at hand via previous research projects.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Specific SL-therapy

Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.

Intervention Type OTHER

Rhythmic Balance-Movement Training (rBMT)

Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.

Intervention Type OTHER

Other Intervention Names

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Specific, intensive and high-frequency SL-therapy

Eligibility Criteria

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Inclusion Criteria

* The patient is able to cooperate
* The patient has the mental competence to provide informed consent to participate in the study
* The patient speaks and understands German

* The patient is responsive to Levodopa (L-DOPA)
* Having received or being scheduled for DBS

Exclusion Criteria

* Severe psychiatric disease difficult to treat (compulsive disorder, depression, mania, psychosis, anxiety as outlined in International Classification of Diseases (ICD-10) (WHO 2015, current version).
* Patient with dementia (DMS-V, Mini-Mental-Status-Test (MMS) \<24, Montreal Cognitive Assessment (MoCa) \<21)
* Secondary Parkinsonism
* Age ≤18 years
* Pregnancy (early onset)
* Presence of a known disease other than PD that shortens the life expectancy
* Mental incompetence to provide informed consent to participate in the study
* Previous intracranial surgery
* Epilepsy
* Contraindications for DBS seen in MRI-scan (malignant tumour, severe microvascular disease)
* Insufficient skills of German language for participating in neuropsychological evaluations
* Sensory problems, severe enough to significantly interfere with neuropsychological assessment
* Alcohol and/or drug addiction

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes